NA 1521-90-054Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295276593), received between Jan 15, 2021 and Dec 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THA SURGERY WITH THE LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2026, THE REVISION SURGERY WILL BE PERFORMED, AND THE POLY LINER AND HEAD WILL BE REPLACED BECAUSE THEY HAD DETERIORATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23844025 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE SCREWS, THE LINER, THE STEM, AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED. THEREFORE, A REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2022. THE IMPLANTS WILL BE DISCARDED, SO THAT THEY WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 15241873 ↗
• InjuryJan 15, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON AN UNKNOWN DATE AT ANOTHER HOSPITAL ((B)(6) HOSPITAL) VIA THA. THE PATIENT HAD UNDERWENT 1ST, 2ND AND 3RD REVISION SURGERY. THE DATES OF 1ST AND 2ND REVISION SURGERY WAS UNKNOWN, THE 3RD REVISION SURGERY WAS PERFORMED ON (B)(6) 2004. THE EXPLANTED IMPLANTS WERE UNKNOWN IN ALL REVISION SURGERY. ONE OF THOSE REVISION SURGERIES INCLUDES A DEBRIDEMENT, HOWEVER, DETAIL INFORMATION OF ALL REVISION SURGERIES WERE UNKNOWN. IT WAS REPORTED THAT THE 4TH REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 BY REPLACING THE CUP (MANUFACTURED BY ZIMMER BIOMET) AND THE HEAD DUE TO REPETITIVE DISLOCATION. CONSIDER THE PATIENT'S AGE AND ACTIVITY, THE SURGEON REMAINED THE STEM, BY REPLACING THE HEAD, GOT THE OFFSET LENGTH (IMPLANTED NEW HEAD IS 36MM/+3 SIZE). THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT INFECTED COVID-19. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 11179010 ↗